Sevoflurane E_Vap — Class II medical device recall Z-2950-2024
Ongoing recall by Mindray DS USA, Inc. dba Mindray North America, reported 2024-09-11, distributed in CA, GA, KY, MS, NJ, PR, TX, WV. V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within t
| Recall number | Z-2950-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2024-07-22 |
| Classified | 2024-09-04 |
| Reported by FDA | 2024-09-11 |
| Distributed | CA, GA, KY, MS, NJ, PR, TX, WV |
| Countries outside the US | CA |
| Quantity | 96 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 06936415975777 |
| Serial numbers | AH6A24000195, AH6A24000199, AH6A24000202, AH6A24000207, AH6A25000237, AH6A27000378, AH6A28000426, AH6A28000457, AH6A28000466, AH6A28000471, AH6A28000474 |
| Model numbers | 115-066756-00 |
Product
Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00
Reason for recall
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2950-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.